Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-07-07FDA-DeviceRemote Diagnostic Technologies Ltd.Class IITempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).
The Tempus Pro (Trizeps 7 only) when used in combination with a specified laryngoscope device can cause two error types when subsequently unplugged.
- 2021-07-07FDA-DeviceFlowonix Medical IncClass IIPhysician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II Programmable 40mLPump 00810335020242
Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection
- 2021-07-07FDA-DeviceCAREFUSIONClass IIMaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
- 2021-07-07FDA-DeviceBard Access Systems Inc.Class II5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
- 2021-07-07FDA-DeviceSmiths Medical ASD Inc.Class IIPORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
- 2021-07-07FDA-DeviceBard Access Systems Inc.Class II5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Catheter kits contained the incorrect micro-introducers.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DevicePhilips North America LlcClass IIContinuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
- 2021-07-07FDA-DeviceNeuMoDx Molecular IncClass IINeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
- 2021-07-07FDA-DeviceExactech, Inc.Class IIHumeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to func
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
- 2021-07-07FDA-DeviceMedtronic Vascular, Inc.Class IIEndurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
- 2021-07-07FDA-DeviceSPINEART SAClass IIPERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
- 2021-07-07FDA-DeviceSpes MedicaClass IITripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- 2021-07-07FDA-DeviceSpes MedicaClass IISNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- 2021-07-07FDA-DeviceSpes MedicaClass IIDragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- 2021-07-07FDA-DeviceSpes MedicaClass IISNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- 2021-07-07FDA-DeviceSpes MedicaClass IIDragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M. for continuous EMG monitoring of the larynx during surgical procedures.
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
There is a potential that the pressure tubing may detach from the blood sampling system
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
There is a potential that the pressure tubing may detach from the blood sampling system
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
There is a potential that the pressure tubing may detach from the blood sampling system
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